Penicillamine
Penicillamine Capsules USP
Approved
Approval ID
b9527635-8f7a-4a77-b39c-cdf678cff827
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2021
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Penicillamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-970
Application NumberANDA209921
Product Classification
M
Marketing Category
C73584
G
Generic Name
Penicillamine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2021
FDA Product Classification
INGREDIENTS (10)
PENICILLAMINEActive
Quantity: 250 mg in 1 1
Code: GNN1DV99GX
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT